The Gross law firm has filed a class action lawsuit against Bluebird on behalf of shareholders who purchased between April 24 2023 and December 8 2023.
IMO, Blue has not committed the securities law violations alleged (which have not been named or enumerated, btw), and any lawsuit going forward should be filed against the FDA for their issuance of the "Blackbox" warning. Blue stated previously they intend to address the non-award of the PRV with the FDA. They should also be pursuing removal of the "Blackbox" warning; if the Blackbox warning had teeth, the clinical trial hold should never have been lifted in the first place - but the FDA vindicated BLUE from this previously. Furthermore, if BLUE did commit securities fraud (again, unspecified how), then that falls onto the regulatory agency moreso than BLUE, IMO.
Honestly - if not a single analyst anticipated the Blackbox warning, this is all a malignant waste of time by the FDA.
[ALLEGATIONS: According to the complaint, on December 8, 2023, Blue announced that the Food and Drug Administration (FDA) approved its drug Lyfgenia (lovotibeglogene autotemcel), also known as lovo-cel for the treatment of sickle cell disease in patients ages 12 and older who have a history of vaso-occlusive events (VOEs). However, the Lyfgenia approval came with a black box warning for haematological malignancies after two patients developed AML during the clinical trials. Analysts noted that they did not expect the black box warning or the absence of a priority review voucher. Following this news, Blue's stock price fell by $1.95 per share, or approximately 40% to close at $2.86 per share.]
